New Zealand Legislation: Acts
Acts are laws made by Parliament
Reprint as at 22 September 2011
| Public Act | 1981 No 118 |
| Date of assent | 23 October 1981 |
| Commencement | see section 1(2) |
Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this reprint.
A general outline of these changes is set out in the notes at the end of this reprint, together with other explanatory material about this reprint.
This Act is administered by the Ministry of Health.
1 Short Title and commencement
3 Meaning of medicine, new medicine, prescription medicine, and restricted medicine
4 Meaning of therapeutic purpose
5 Meaning of selling by wholesale, selling by retail, and selling in circumstances corresponding to retail sale
5A Relationship with Hazardous Substances and New Organisms Act 1996
5A Meaning of holding an interest in a pharmacy
5B Meaning of operating a pharmacy
Part 1
Application and administration of Act
8 Advisory and technical committees
9 Medicines Classification Committee
10 Medicines Review Committee established
12 Committee may appoint subcommittees
13 Functions, powers, and procedures of Medicines Review Committee
16 Exercise of powers of Director-General and other officers
Part 2
Dealings with medicines and medical devices
17 Manufacturers, wholesalers, packers of medicines, and operators of pharmacies to be licensed
18 Sale of medicines by retail
19 Administering prescription medicines
20 Restrictions on sale or supply of new medicines
21 Applications for Minister's consent
22 Procedure in respect of applications for Minister's consent
23 Minister may give provisional consent
23B Protection of confidential supporting information about innovative medicines
23C Circumstances where protection under section 23B does not apply
24 Distribution of changed medicines restricted
24A Assessment of qualifying new medicines
24B Procedure if Director-General declines to grant approval
Approval of medicines required for use in special emergency
24D Approval of medicines required for use in special emergency
24E Notification or publication of approval
24G Consequences of expiry of approval
25 Exemptions for practitioners and others
27 Exemptions for veterinarians and certain registered health practitioners
28 Exemptions in respect of herbal remedies
29 Exemption for medicine required by medical practitioner
30 Exemption for clinical trial
31 Exemptions for agents and employees
32 Exemptions for natural therapists and others
32A Exemptions in respect of importation by the Crown
33 Exemptions in respect of procuring and exporting medicines
34 Exemption for sale by wholesale of medicines that are not prescription, restricted, or pharmacy-only medicines
35 Revocation and suspension of consents
36 Control of established medicines
37 Powers of Minister to prohibit import, etc, of medicines
38 Restrictions on sale of medical devices
41 Duty of importer or manufacturer to report untoward effects of medicines
42 Duty of importer and manufacturer to have and produce specifications of medicines
Restrictions on operation of pharmacies
42A Every pharmacy must be under supervision of pharmacist
42C Restriction on authorised prescribers holding interest in pharmacies
43 Restrictions on possession of prescription medicines
44 Containers and packages of medicines
47 Storage and delivery of medicines
48 Powers of Minister to prohibit prescribing, etc
48A Powers of councils and boards
49 Restrictions on supply to particular persons
49A Statements regarding persons dependent on prescription medicines or restricted medicines
Part 3
Provisions relating to licences
55A Additional criteria to be satisfied by pharmacy operators
55B Licensing authority may require further information
55C Mandatory condition of licence to operate pharmacy
Restrictions on persons allowed to operate pharmacies
55D Restriction on companies operating pharmacies
55E Restriction on individuals operating or holding majority interest in pharmacies
55F Prohibition on operating or holding of majority interest in more than 5 pharmacies
55G Exemption for mortgagees in possession
57 Restrictions on advertisements
58 Further restrictions on advertisements
59 Advertisements to contain true name of advertiser
60 Exemption for certain advertisements
62 Regulations relating to advertisements
64 Further provisions relating to seizure and detention of articles
65 District Court may order return of property or compensation
66 Powers to require information
67 Power to require name and address of seller
68 Source of information or reports need not be disclosed
69 Procuring samples for analysis
70 Analysis of sample and certificate of analyst
72 Special provisions relating to imported consignments
74 Certificates of Director-General or Medical Officer of Health
76 Penalty for false statement
76A Offences in relation to authorised prescribers
77 Jurisdiction of District Courts
79 Liability of principal for acts of agents, etc
82 Liability of persons named on labels
84 Payment of expenses of analysis on conviction
86 Courts may order withdrawal of goods from circulation
87 Notification of conviction of practitioners, etc
88 Refusal of licensing authority to grant licence
89 Right of appeal to High Court
91 Further provisions relating to appeals
92 Court may state case for Court of Appeal
93 Appeal to Court of Appeal in certain cases
95 Application of Act to related products
96 Certain provisions to apply to related products as if medicines
Part 7A
Restrictions on specified biotechnical procedures
96B Restrictions on specified biotechnical procedures
96C Authorisation of particular procedures
96D Authorisation of class of procedure
96E Criteria for authorisations
96F Advice on applicability of criteria
Part 8
Miscellaneous provisions
97 Duty of officer to procure samples for analysis on request
98 Statement by Director-General
99 Director-General to publish lists of general sale medicines
100 Power of court to restrict publication of name of medicine
101 Examination of Customs entries
102 Protection of persons acting under authority of Act
105A Regulations relating to practitioners, veterinarians, and registered midwives
105B Regulations relating to designated prescribers
105C Orders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation
106 Minister may classify medicines by notice in the Gazette
107 Power to obtain information for purposes of regulations
109 Relationship with Misuse of Drugs Act 1975
110 Relationship with Hazardous Substances and New Organisms Act 1996
111 Amendment of and effect on Animal Remedies Act 1967 [Repealed]
112 Amendment of Consumer Information Act 1969 [Repealed]
113 Amendment of Ombudsmen Act 1975
114A Certain persons deemed to have licence to operate pharmacy [Expired]
An Act to consolidate and amend the law relating to the manufacture, sale, and supply of medicines, medical devices, and related products
